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FDA Accepts NDA for Preos, Treatment for Osteoporosis in Postmenopausal Women
Clinical results in the NDA are based upon data from 13 separate studies including an international multi-center Phase 3 trial of approximately 2,600 postmenopausal osteoporotic women who were randomized to receive either a daily subcutaneous injection of 100 micrograms of PREOS(R) or placebo, in addition to daily calcium and vitamin D supplements. The application also includes results from Phase 1 and Phase 2 studies with PREOS(R), open-label extension studies following the pivotal Phase 3 trial, and combination studies evaluating the use of PREOS(R) with other drugs, as well as preclinical data and data related to manufacturing the product.
A similar application to market PREOS(R) in Europe under the brand name PREOTACT(TM) is currently under review by the European Medicines Agency.
Source: NPS Pharmaceuticals